Phase I study helps company secure second indication for lead product

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Early clinical-stage US biotech DiaMedica engaged Novotech to help it take advantage of Australia’s supportive early stage research environment and the country’s speedy regulatory system. 

The Background 

Early clinical-stage US biotech DiaMedica was keen to take advantage of Australia’s supportive early stage research environment for its next phase I study, but knew it would require guidance in accessing the country’s speedy regulatory system and large network of phase I units. 

Challenge 

Appreciating Novotech’s depth of regional experience, DiaMedica engaged the CRO to help them select a phase I unit and manage the clinical trial in Australia. 

Novotech reviewed the proposed protocol and worked with DiaMedica to finalise a number of manufacturing and clinical trial logistic elements. Novotech advised DiaMedica to engage a private phase I unit for the trial, allowing the company to access a private ethics committee and speedy regulatory approval process – saving DiaMedica up to two months in pertinent start up time as compared to having engaged a public site and ethics committee. 

Our Actions 

Working with the chosen phase I unit, Novotech project managed the trial exceeded target and recruited over 50 healthy volunteers. As part of its clinical trial management service, Novotech was also able to provide DiaMedica with access to several high-level IT platforms such as ARGUS, SharePoint, EDC and IMedidata. 

Results 

Novotech’s team for DiaMedica managed the trial from start to finish, providing medical writing and clinical trial management. Armed with positive data from the trial, DiaMedica was able to expand its breadth of their product to include a second indication. 

“Despite never having undertaken research in the country before, we knew undertaking our phase I trial in Australia would be a great opportunity for the company, clinically and financially – but we also knew we would need a regional specialist to access these benefits. Novotech understood our both our clinical and business needs and our limitations. They provided clear and insightful guidance at every step. They made it clear from the start they saw themselves as a being our research ‘partner’, not just a service provider.” 

DiaMedica, Chief Scientific Officer